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HIV-1 infection

Infectious Disease 4 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

Infectious Disease indication. HIV-1 infection has 4 FDA-approved novel treatments, led by Merck across 4 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

HIV-1 infection Market Leaders

Companies with the most FDA-approved novel HIV-1 infection drugs.

Phase 3 Readouts Pro

6 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q3 2027

MK-8527

Merck

Estimated · fresh NCT07044297

Q4 2027

MK-8527

Merck

Estimated · fresh NCT07071623

Q1 2029

ISL

Merck

Estimated · fresh NCT07266831

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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

HIV-1 infection Treatments by Mechanism

Top 11 mechanisms across 42 industry trials with a known mechanism of action.

See full pipeline →

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor

10 trials 1 active 1 sponsor

Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor

9 trials 1 active 6 sponsors

Protease Inhibitor

7 trials 4 sponsors

CCR5 Co-receptor Antagonist

6 trials 2 sponsors

Cytochrome P450 3A Inhibitor

4 trials 2 sponsors

Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor

1 trials 1 sponsor

DNA

1 trials 1 sponsor

Alkylating Drug

1 trials 1 sponsor

Thalidomide Analog

1 trials 1 sponsor

Azole Antifungal

1 trials 1 sponsor

CD30-directed Immunoconjugate

1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

HIV-1 infection Clinical Pipeline by Phase

399 industry-sponsored trials across 69 sponsors

Showing 17 of 17 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Janssen Scientific Affairs, LLC	D/C/F/TAF FDC	—	COMPLETED	2023-08-07	NCT04442737
Napo Pharmaceuticals, Inc.	Crofelemer delayed-release tablets 125mg	—	COMPLETED	2021-08-31	NCT04192487
Merck	Raltegravir	—	COMPLETED	2018-10-23	NCT03667547
ViiV Healthcare	Dolutegravir 50 mg	—	COMPLETED	2018-10-01	NCT03314064
ViiV Healthcare	Lamivudine	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2016-03-01	NCT02634073
Gilead	STB	—	COMPLETED	2016-01-20	NCT02246998
Janssen R&D Ireland	Etravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2013-11	NCT01422330
ViiV Healthcare	HIV therapy	—	COMPLETED	2012-10	NCT01275625
Johnson & Johnson	TMC114/ritonavir	—	COMPLETED	2012-06	NCT01702090
ViiV Healthcare	Reyataz + Norvir + Truvada	—	COMPLETED	2012-06	NCT01102972
Bristol-Myers Squibb	Atazanavir	—	COMPLETED	2011-06	NCT01232127
Gilead	emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)	—	COMPLETED	2011-03	NCT00724711
Gilead	Truvada + Kaletra	—	COMPLETED	2009-09	NCT00772902
Tibotec, Inc	ritonavir	Cytochrome P450 3A Inhibitor [EPC]	COMPLETED	2009-08	NCT00757783
ViiV Healthcare	Maraviroc	CCR5 Co-receptor Antagonist [EPC]	COMPLETED	2008-11	NCT00717067
Theratechnologies	Tesamorelin	—	TERMINATED	2018-05	NCT01591902
ViiV Healthcare	maraviroc	CCR5 Co-receptor Antagonist [EPC]	WITHDRAWN	2010-02	NCT00782301

Showing 100 of 109 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Merck	MK-8527	—	RECRUITING	2027-07-22	NCT07044297
Merck	MK-8527	—	RECRUITING	2027-10-18	NCT07071623
Merck	ISL	—	RECRUITING	2029-03-21	NCT07266831
Merck	MK-8591A	—	ACTIVE NOT RECRUITING	2029-05-29	NCT04776252
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	ACTIVE NOT RECRUITING	2026-03-24	NCT05979311
Merck	DOR/ISL	—	ACTIVE NOT RECRUITING	2025-10-16	NCT05766501
Merck	DOR/ISL	—	ACTIVE NOT RECRUITING	2025-10-13	NCT05705349
Gilead	B/F/TAF (Adult Strength)	—	ACTIVE NOT RECRUITING	2025-03-24	NCT02881320
Merck	DOR/ISL	—	ACTIVE NOT RECRUITING	2024-10-25	NCT05630755
Merck	ART	—	ACTIVE NOT RECRUITING	2024-10-10	NCT05631093
Gilead	Oral Lenacapavir (LEN)	—	ACTIVE NOT RECRUITING	2024-08-21	NCT04925752
Gilead	Oral Lenacapavir (LEN)	—	ACTIVE NOT RECRUITING	2024-05-27	NCT04994509
Gilead	F/TAF	—	ACTIVE NOT RECRUITING	2019-01-31	NCT02842086
ViiV Healthcare	Cabotegravir (CAB) tablet	—	ACTIVE NOT RECRUITING	2018-05-29	NCT02951052
United BioPharma	UB-421	—	NOT YET RECRUITING	2026-06-30	NCT04406727
ViiV Healthcare	DTG/3TC	—	COMPLETED	2026-01-23	NCT05911360
ViiV Healthcare	Cabotegravir - Injectable Suspension (CAB LA)	—	COMPLETED	2023-09-14	NCT05896748
Merck	ISL	—	COMPLETED	2022-11-21	NCT04233216
Merck	DOR/ISL	—	COMPLETED	2022-11-17	NCT04233879
ViiV Healthcare	Cabotegravir Injectable Suspension	—	COMPLETED	2022-08-23	NCT05896761
Merck	DOR/ISL	—	COMPLETED	2021-09-08	NCT04223778
Merck	DOR/ISL	—	COMPLETED	2021-08-26	NCT04223791
Johnson & Johnson	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2021-07-29	NCT01281813
Johnson & Johnson	Etravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2020-11-25	NCT00980538
CytoDyn, Inc.	PRO 140 (350 mg)	—	COMPLETED	2020-09-16	NCT02859961
Janssen R&D Ireland	Rilpivirine	—	COMPLETED	2020-02	NCT01266902
Gilead	F/TAF	—	COMPLETED	2019-11-04	NCT02285114
Gilead	B/F/TAF	—	COMPLETED	2019-08-12	NCT03631732
Sanofi	Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine	—	COMPLETED	2019-02-22	NCT02817451
Janssen Scientific Affairs, LLC	DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC	—	COMPLETED	2019-01-03	NCT03227861
Gilead	B/F/TAF	—	COMPLETED	2018-11-20	NCT03405935
TaiMed Biologics Inc.	ibalizumab	—	COMPLETED	2018-11	NCT02707861
ViiV Healthcare	DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets	—	COMPLETED	2018-10-22	NCT02075593
Gilead	E/C/F/TAF	—	COMPLETED	2018-10-11	NCT02616029
International Partnership for Microbicides, Inc.	—	—	COMPLETED	2018-10-10	NCT02858037
ViiV Healthcare	Dolutegravir (DTG)	—	COMPLETED	2018-04-04	NCT02831764
ViiV Healthcare	Dolutegravir (DTG)	—	COMPLETED	2018-03-29	NCT02831673
Merck	Doravirine, Tenofovir, Lamivudine	—	COMPLETED	2018-02-22	NCT02397096
Gilead	E/C/F/TAF	—	COMPLETED	2018-02-21	NCT02616783
CytoDyn, Inc.	PRO 140	—	COMPLETED	2018-02	NCT02483078
Gilead	F/TAF	—	COMPLETED	2017-12-11	NCT02469246
ViiV Healthcare	DTG 50 mg	—	COMPLETED	2017-11-02	NCT02178592
Gilead	E/C/F/TAF	—	COMPLETED	2017-10-09	NCT02652624
Gilead	E/C/F/TAF	—	COMPLETED	2017-09-29	NCT02600819
Gilead	E/C/F/TAF	—	COMPLETED	2017-09-14	NCT02707601
Gilead	E/C/F/TAF	—	COMPLETED	2017-06-14	NCT02605954
Gilead	RTV	—	COMPLETED	2017-05-15	NCT02603107
Gilead	DTG	—	COMPLETED	2017-05-12	NCT02607956
Gilead	ABC/DTG/3TC	—	COMPLETED	2017-05-09	NCT02607930
Gilead	ABC/DTG/3TC	—	COMPLETED	2017-05-09	NCT02603120
Merck	Doravirine, Tenofovir, Lamivudine	—	COMPLETED	2017-03-20	NCT02403674
AbbVie	ABT-493 coformulated with ABT-530	—	COMPLETED	2017-03-15	NCT02738138
Janssen R&D Ireland	D/C/F/TAF	—	COMPLETED	2017-02	NCT02269917
Gilead	E/C/F/TAF	—	COMPLETED	2016-11-10	NCT02276612
TaiMed Biologics Inc.	ibalizumab	—	COMPLETED	2016-10	NCT02475629
Merck	Doravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2016-09-29	NCT02275780
Janssen Scientific Affairs, LLC	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2016-08-11	NCT00855335
AbbVie	ABT-450/r/ABT-267	—	COMPLETED	2016-07-21	NCT01939197
Gilead	FTC/RPV/TAF	—	COMPLETED	2016-06-29	NCT02345226
Gilead	FTC/RPV/TAF	—	COMPLETED	2016-06-22	NCT02345252
Merck	Reformulated Raltegravir	—	COMPLETED	2015-12-21	NCT02131233
Janssen-Cilag International NV	Rilpivirine	—	COMPLETED	2015-10-22	NCT01709084
Institut Pasteur	cotrimoxazole daily prophylaxis	—	COMPLETED	2015-10	NCT01746199
ViiV Healthcare	Dolutegravir/abacavir/lamivudine FDC	—	COMPLETED	2015-09-22	NCT01910402
Biocad	Algeron	—	COMPLETED	2015-08-26	NCT02103439
Gilead	FTC/TDF	—	COMPLETED	2015-08-12	NCT02121795
Gilead	E/C/F/TAF	—	COMPLETED	2015-07-21	NCT01968551
Gilead	TAF	—	COMPLETED	2015-05-21	NCT01967940
ViiV Healthcare	ABC/DTG/3TC FDC	—	COMPLETED	2015-04	NCT02105987
Gilead	E/C/F/TAF	—	COMPLETED	2015-03-16	NCT01815736
Gilead	E/C/F/TAF	—	COMPLETED	2015-01-23	NCT02071082
Gilead	LDV/SOF	—	COMPLETED	2014-11	NCT02073656
Gilead	E/C/F/TAF	—	COMPLETED	2014-09-19	NCT01797445
Bristol-Myers Squibb	Atazanavir Sulphate	—	COMPLETED	2014-09-10	NCT01335698
Gilead	E/C/F/TAF	—	COMPLETED	2014-08-26	NCT01780506
Gilead	E/C/F/TAF	—	COMPLETED	2014-07-31	NCT01818596
Janssen-Cilag International NV	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2014-06-11	NCT01448707
Gilead	Sofosbuvir	Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]	COMPLETED	2014-04	NCT01783678
Gilead	SOF	—	COMPLETED	2013-11	NCT01667731
Janssen-Cilag G.m.b.H	Darunavir/Ritonavir (DRV/r)	—	COMPLETED	2013-08-01	NCT01516970
ViiV Healthcare	dolutegravir 50 mg OAD	—	COMPLETED	2013-04-22	NCT01449929
ViiV Healthcare	GSK1349572	—	COMPLETED	2013-02-04	NCT01231516
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2012-10	NCT01499199
Gilead	FTC/RPV/TDF	—	COMPLETED	2012-09	NCT01309243
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2012-05-14	NCT01263015
ViiV Healthcare	dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2012-05	NCT01328041
ViiV Healthcare	GSK1349572 (dolutegravir)	—	COMPLETED	2012-02-06	NCT01227824
Gilead	FTC/RPV/TDF	—	COMPLETED	2012-01	NCT01252940
Gilead	COBI	—	COMPLETED	2011-11	NCT01108510
Gilead	Stribild	Cytochrome P450 3A Inhibitor [EPC]	COMPLETED	2011-09	NCT01106586
Chiltern Pesquisa Clinica Ltda	Focetria®	—	COMPLETED	2011-09	NCT01032408
Gilead	Stribild	Cytochrome P450 3A Inhibitor [EPC]	COMPLETED	2011-08	NCT01095796
Merck	Comparator: raltegravir	—	COMPLETED	2011-02	NCT00764946
Gilead	Elvitegravir	—	COMPLETED	2010-12	NCT00708162
Tibotec Pharmaceuticals, Ireland	TMC278	—	COMPLETED	2010-02	NCT00540449
Tibotec Pharmaceuticals, Ireland	TMC278	—	COMPLETED	2010-01	NCT00543725
Abbott	lopinavir/ritonavir (LPV/r)	—	COMPLETED	2009-11	NCT00711009
Abbott Diagnostics Division	—	—	COMPLETED	2009-10	NCT00933933
Merck	Islatravir	—	TERMINATED	2023-07-18	NCT04644029
CytoDyn, Inc.	PRO 140	—	TERMINATED	2022-06	NCT02990858

Showing 100 of 100 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Henan Genuine Biotech Co., Ltd.	CL-197 capsules	—	RECRUITING	2026-12	NCT07308782
Merck	Doravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	RECRUITING	2028-11-12	NCT04375800
Shanxi Kangbao Biological Product Co., Ltd.	LP-98 20 mg	—	RECRUITING	2026-07-10	NCT07433387
Jiangsu Aidea Pharmaceutical Group Co., Ltd.	ACC017+FTC/TAF	—	RECRUITING	2025-08	NCT06719310
Code Pharma	Dispensing Codivir®	—	RECRUITING	2024-12	NCT06676410
Johnson & Johnson	Rilpivirine	—	ACTIVE NOT RECRUITING	2026-08-18	NCT02494986
Merck	ISL	—	ACTIVE NOT RECRUITING	2027-08-10	NCT06891066
Gilead	Lenacapavir Injection	—	ACTIVE NOT RECRUITING	2028-01	NCT06101342
Gilead	Lenacapavir Tablet	—	ACTIVE NOT RECRUITING	2026-07	NCT06101329
Gilead	Lenacapavir Injection	—	ACTIVE NOT RECRUITING	2026-05-28	NCT06513312
Gilead	Teropavimab	—	ACTIVE NOT RECRUITING	2024-07-02	NCT05729568
Gilead	ISL	—	ACTIVE NOT RECRUITING	2023-12-19	NCT05052996
MGB Pharma	The monoterpenoid zinc tetra-ascorbo-camphorate ("C14")	—	NOT YET RECRUITING	2025-03-15	NCT06672653
Merck	Islatravir	—	COMPLETED	2025-01-30	NCT04564547
Shanxi Kangbao Biological Product Co., Ltd.	Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.	—	COMPLETED	2025-01-10	NCT06560489
Merck	MK-8527	—	COMPLETED	2024-12-12	NCT06045507
Shanxi Kangbao Biological Product Co., Ltd.	Lipovirtide 10mg	—	COMPLETED	2024-11-29	NCT06061536
Johnson & Johnson	Rilpivirine	—	COMPLETED	2023-02-17	NCT04012931
United BioPharma	UB-421	—	COMPLETED	2023-02-01	NCT05056974
Sanofi	CYD Dengue Vaccine	—	COMPLETED	2023-01-19	NCT02741128
Johnson & Johnson	Rilpivirine	—	COMPLETED	2022-08	NCT00799864
Merck	Islatravir	—	COMPLETED	2022-03-18	NCT04003103
Merck	DOR/ISL	—	COMPLETED	2021-12-21	NCT04295772
Merck	Islatravir	—	COMPLETED	2021-03-08	NCT03272347
United BioPharma	UB-421(25 mg/kg) Q2W	—	COMPLETED	2020-10-15	NCT03743376
Merck	Doravirine/lamivudine/tenofovir disoproxil fumarate	—	COMPLETED	2018-11-28	NCT02629822
Janssen Vaccines & Prevention B.V.	Ad26.Mos.HIV	—	COMPLETED	2018-09	NCT02919306
Merck	Doravirine, Tenofovir, Lamivudine - Blinded	—	COMPLETED	2018-08-14	NCT02652260
Environment and Health Group, Inc.	—	—	COMPLETED	2018-06-30	NCT03810170
Sangamo Therapeutics	Cyclophosphamide	DNA	COMPLETED	2018-06	NCT02225665
GSK	GSK2838232	—	COMPLETED	2018-04-23	NCT03045861
Johnson & Johnson	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2017-11-23	NCT01138605
Calimmune, Inc.	Busulfan	Alkylating Drug [EPC]	COMPLETED	2017-09	NCT01734850
Abivax S.A.	ABX464	—	COMPLETED	2017-08-30	NCT02735863
Sangamo Therapeutics	—	—	COMPLETED	2017-07-07	NCT01543152
International Partnership for Microbicides, Inc.	—	—	COMPLETED	2016-07-05	NCT02028338
United BioPharma	UB-421	—	COMPLETED	2016-07	NCT02369146
Abivax S.A.	ABX464	—	COMPLETED	2015-12	NCT02452242
Gilead	BIC	—	COMPLETED	2015-11-30	NCT02397694
ViiV Healthcare	CAB Oral Tablets	—	COMPLETED	2015-08-13	NCT02120352
ViiV Healthcare	744 Tablet	—	COMPLETED	2015-05-15	NCT02076178
International Partnership for Microbicides, Inc.	Dapivirine Vaginal Ring	—	COMPLETED	2015-04	NCT02010593
CytoDyn, Inc.	PRO 140	—	COMPLETED	2015-02-02	NCT02175680
Sangamo Therapeutics	SB-728-T	—	COMPLETED	2014-12	NCT01252641
ViiV Healthcare	BMS-955176	—	COMPLETED	2014-11-29	NCT01803074
Gilead	Simtuzumab	—	COMPLETED	2014-10-17	NCT01707472
Theravectys S.A.	THV01-1	—	COMPLETED	2014-08	NCT02054286
Bionor Immuno AS	Lenalidomide	Thalidomide Analog [EPC]	COMPLETED	2014-08	NCT01704781
Argos Therapeutics	AGS-004	—	COMPLETED	2014-08	NCT01069809
United Biomedical	Antibody UB-421	—	COMPLETED	2014-03	NCT01668043
Bionor Immuno AS	Vacc-4x	—	COMPLETED	2014-01	NCT01712256
Merck	Raltegravir Film-coated Tablet	—	COMPLETED	2013-12-11	NCT01717287
Viriom	VM-1500/Placebo	—	COMPLETED	2013-12	NCT02485509
Bionor Immuno AS	Vacc-C5/GM-CSF	—	COMPLETED	2013-11	NCT01627678
ViiV Healthcare	GSK1265744 10 mg	—	COMPLETED	2013-10-10	NCT01641809
Gilead	SOF	—	COMPLETED	2013-08	NCT01565889
ViiV Healthcare	BMS-663068 400 mg	—	COMPLETED	2013-02-18	NCT01384734
InnaVirVax	VAC-3S	—	COMPLETED	2013-02	NCT01549119
Tobira Therapeutics, Inc.	Cenicriviroc 100 mg	—	COMPLETED	2012-12	NCT01338883
Tibotec, Inc	Etravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2012-10	NCT01199939
Genetic Immunity	DermaVir	—	COMPLETED	2011-12	NCT00711230
Pfizer	UK-453, 061	—	COMPLETED	2011-10	NCT00824421
Gilead	FTC/RPV/TDF	—	COMPLETED	2011-07	NCT01286740
Tibotec Pharmaceuticals, Ireland	Etravirine (TMC125)	—	COMPLETED	2011-05	NCT00665847
TaiMed Biologics Inc.	Ibalizumab	—	COMPLETED	2011-04	NCT00784147
Janssen-Cilag S.p.A.	Darunavir(DRV)	—	COMPLETED	2011-04	NCT01391013
International Partnership for Microbicides, Inc.	dapivirine 4789	—	COMPLETED	2011-01-08	NCT00799058
ViiV Healthcare	GSK1349572 (Cohort I)	—	COMPLETED	2010-11	NCT00950859
Tibotec Pharmaceuticals, Ireland	darunavir	Protease Inhibitor [EPC]	COMPLETED	2010-09	NCT00915655
Tibotec Pharmaceuticals, Ireland	Darunavir	Protease Inhibitor [EPC]	COMPLETED	2010-08	NCT00919854
ViiV Healthcare	maraviroc	CCR5 Co-receptor Antagonist [EPC]	COMPLETED	2010-07	NCT00827112
ViiV Healthcare	GSK1349572	—	COMPLETED	2010-02-26	NCT00951015
Janssen-Cilag International NV	etravirine (ETR, TMC125)	—	COMPLETED	2010-02	NCT00903682
Gilead	COBI	—	COMPLETED	2009-12	NCT00892437
ViiV Healthcare	GSK2248761	—	COMPLETED	2009-11-28	NCT00945282
Gilead	Stribild	Cytochrome P450 3A Inhibitor [EPC]	COMPLETED	2009-11	NCT00869557
Tobira Therapeutics, Inc.	TBR-652	—	COMPLETED	2009-11	NCT01092104
ViiV Healthcare	GSK1265744 30mg	—	COMPLETED	2009-08-13	NCT00920426
Tibotec Pharmaceuticals, Ireland	TMC310911 75 mg twice daily	—	COMPLETED	2009-08	NCT00838162
Myrexis Inc.	Bevirimat	—	COMPLETED	2009-01	NCT01097070
ViiV Healthcare	GSK1349572	—	COMPLETED	2008-08	NCT00708110
Tibotec, Inc	TMC125; darunavir; ritonavir	—	COMPLETED	2008-05	NCT00534352
CytoDyn, Inc.	PRO 140 350mg weekly subcutaneous (SC) injection.	—	TERMINATED	2022-06	NCT02355184
Janssen Vaccines & Prevention B.V.	Ad26.Mos4.HIV	—	TERMINATED	2022-02-02	NCT03060629
ViiV Healthcare	BMS-955176	—	TERMINATED	2016-05-26	NCT02415595
Pfizer	No drug will be administered	—	TERMINATED	2013-07	NCT00824369
Cytheris SA	Interleukin-7	—	TERMINATED	2013-06	NCT01190111
Cytheris SA	CYT107	—	TERMINATED	2013-06	NCT01241643
Pfizer	lersivirine	—	TERMINATED	2013-04	NCT01254656
Bristol-Myers Squibb	BMS-986001	—	TERMINATED	2013-03	NCT01489046
RFS Pharma, LLC	amdoxovir 300 mg bid	—	TERMINATED	2013-02	NCT01737359
Pfizer	UK-453,061 Dose 1	—	TERMINATED	2012-10-18	NCT00823979
ViiV Healthcare	GSK2248761 100 mg once daily	—	TERMINATED	2011-07-19	NCT01199731
ViiV Healthcare	GSK2248761 100 mg once daily	—	TERMINATED	2011-07-04	NCT01231555
Bristol-Myers Squibb	Atazanavir	—	TERMINATED	2010-01	NCT00768989
Merck	Islatravir	—	WITHDRAWN	2025-10-02	NCT05115838
Merck	Islatravir	—	WITHDRAWN	2024-03-25	NCT05130086
United BioPharma	UB-421	—	WITHDRAWN	2020-12	NCT04041362
CytoDyn, Inc.	PRO 140	—	WITHDRAWN	2017-01	NCT01272258
RFS Pharma, LLC	amdoxovir 300 mg bid	—	WITHDRAWN	2014-08	NCT01738555

Showing 100 of 173 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Immuno Cure Holding (HK) Limited	ICVAX (TERESA-EPT I device)	—	RECRUITING	2027-03-31	NCT07530198
Merck	MK-8527	—	NOT YET RECRUITING	2026-12-22	NCT07600775
Jecho Biopharmaceuticals Co., Ltd.	JL18008	—	NOT YET RECRUITING	2029-12-20	NCT07443228
Merck	MK-4646	—	COMPLETED	2026-06-05	NCT07042945
Immuno Cure Holding (HK) Limited	ICVAX	—	COMPLETED	2024-09-30	NCT06253533
MacroGenics	MGD020	—	COMPLETED	2024-05-29	NCT05261191
Shanxi Kangbao Biological Product Co., Ltd.	LP-98 injection	—	COMPLETED	2024-04-12	NCT05933824
Merck	MK-8527	—	COMPLETED	2024-01-31	NCT05494736
Henan Genuine Biotech Co., Ltd.	1 mg CL-197 capsules	—	COMPLETED	2024-01-20	NCT05944848
Merck	MK-8527	—	COMPLETED	2023-10-11	NCT06783192
AbbVie	ABBV-382	—	COMPLETED	2023-08-14	NCT04554966
AbbVie	ABBV-181	—	COMPLETED	2023-02-27	NCT04223804
AbbVie	Budigalimab	—	COMPLETED	2022-10-11	NCT04799353
Johnson & Johnson	DRV/COBI FDC	—	COMPLETED	2022-09-23	NCT05197075
American Gene Technologies International Inc.	AGT103-T	—	COMPLETED	2022-08-15	NCT04561258
Gilead	Oral Lenacapavir	—	COMPLETED	2022-06-09	NCT04811040
United BioPharma	UB-421 SC(dB4C7C22-6 mAb)	—	COMPLETED	2022-05-25	NCT04620304
Jiangsu HengRui Medicine Co., Ltd.	SHR2150；Placebo	—	COMPLETED	2021-11-10	NCT04802811
Janssen Vaccines & Prevention B.V.	Ad26.Mos4.HIV	—	COMPLETED	2021-11-05	NCT03307915
Merck	Islatravir	—	COMPLETED	2021-09-13	NCT04515641
Merck	Islatravir	—	COMPLETED	2021-07-09	NCT04568603
Merck	Islatravir	—	COMPLETED	2020-10-19	NCT04303156
Aelix Therapeutics	DNA.HTI 0.5mL at weeks 0, 4 and 8 + MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM)	—	COMPLETED	2020-07-01	NCT03204617
Merck	MK-8558	—	COMPLETED	2020-05-29	NCT03859739
Janssen Pharmaceutica N.V., Belgium	D/C/F/TAF FDC placebo	—	COMPLETED	2020-03-06	NCT04006704
Gilead	Vesatolimod	—	COMPLETED	2020-02-13	NCT03060447
Gilead	Lenacapavir	—	COMPLETED	2019-11-14	NCT03739866
Merck	MK-8527	—	COMPLETED	2019-09-26	NCT03615183
ViiV Healthcare	Cabotegravir tablet 30 mg once daily for 28 days.	—	COMPLETED	2019-07-25	NCT02478463
Merck	MK-8583	—	COMPLETED	2019-03-11	NCT03552536
Gilead	Vesatolimod	—	COMPLETED	2019-02-14	NCT02858401
Antiva Biosciences	ABI-1968	—	COMPLETED	2019-02-04	NCT03202992
Merck	MK-4250	—	COMPLETED	2018-11-02	NCT03351699
ViiV Healthcare	GSK3640254	—	COMPLETED	2018-09-09	NCT03231943
KBio Inc	MB66	—	COMPLETED	2018-07	NCT02579083
Merck	MK-8504	—	COMPLETED	2018-05-21	NCT03188523
International Partnership for Microbicides, Inc.	Dapivirine	—	COMPLETED	2018-03-03	NCT02808949
GSK	—	—	COMPLETED	2018-01-30	NCT03368053
GSK	GSK2838232 100 mg tablet	—	COMPLETED	2017-11-10	NCT03234036
ViiV Healthcare	Cabotegravir	—	COMPLETED	2017-09-06	NCT03149848
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2017-08-18	NCT03078556
Johnson & Johnson	DRV/COBI FDC placebo tablet	—	COMPLETED	2017-05-25	NCT02993237
Merck	1 mg islatravir	—	COMPLETED	2017-05-11	NCT02217904
GSK	GSK2838232 PIB	—	COMPLETED	2016-12	NCT02795754
ViiV Healthcare	GSK1265744 30 mg	—	COMPLETED	2016-11-01	NCT02354937
ViiV Healthcare	DTG/ABC/3TC FDC DISPERSIBLE TABLET	—	COMPLETED	2016-11-01	NCT02893488
ViiV Healthcare	DTG	—	COMPLETED	2016-10-24	NCT02741557
International Partnership for Microbicides, Inc.	DS003 vaginal tablet	—	COMPLETED	2016-08-26	NCT02877979
ViiV Healthcare	BMS-955176	—	COMPLETED	2016-08-15	NCT02273947
ViiV Healthcare	BMS-663068 (1 tablet at 600 mg)	—	COMPLETED	2016-08-12	NCT02859259
ViiV Healthcare	Cabotegravir 30 mg	—	COMPLETED	2016-08	NCT02799264
ViiV Healthcare	BMS-663068	—	COMPLETED	2016-06-29	NCT02666001
Merck	Methadone	—	COMPLETED	2016-06-13	NCT02715700
ViiV Healthcare	Dolutegravir 50 mg tablet	—	COMPLETED	2016-06	NCT02738931
ViiV Healthcare	BMS-663068	—	COMPLETED	2016-05-05	NCT02805556
ViiV Healthcare	Dolutegravir	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2016-05	NCT02715479
Janssen Infectious Diseases BVBA	Rilpivirine (RPV)	—	COMPLETED	2016-04-26	NCT02547870
International Partnership for Microbicides, Inc.	Dapivirine Vaginal Ring-004 and no tampons	—	COMPLETED	2016-04-16	NCT02858024
ApoPharma	Intravenous deferiprone	—	COMPLETED	2016-03	NCT02456558
ViiV Healthcare	BMS-663068	—	COMPLETED	2016-02-22	NCT02666053
ViiV Healthcare	BMS-663068	—	COMPLETED	2016-01-11	NCT02480881
Merck	Treatment A: Doravirine 100 mg film coated tablet	—	COMPLETED	2015-12-24	NCT02549040
ViiV Healthcare	BMS-663068	—	COMPLETED	2015-11-05	NCT02508064
ViiV Healthcare	ABC/DTG/3TC FDC tablet	—	COMPLETED	2015-11	NCT02539576
ViiV Healthcare	BMS-663068	—	COMPLETED	2015-10-03	NCT02467335
ViiV Healthcare	BMS-663068	—	COMPLETED	2015-09-21	NCT02480894
ViiV Healthcare	DTG 50 mg	—	COMPLETED	2015-09	NCT02373930
ViiV Healthcare	CAB	—	COMPLETED	2015-09	NCT02411435
Merck	Raltegravir 1200 mg	—	COMPLETED	2015-08-29	NCT02473367
Merck	Ulonivirine	—	COMPLETED	2015-07-16	NCT02174159
Gilead	Bictegravir	—	COMPLETED	2015-07-06	NCT02400307
Ratiopharm GmbH	Nevirapine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2015-07	NCT02202005
ViiV Healthcare	Cabotegravir 30 mg current formulation	—	COMPLETED	2015-06	NCT02345707
Gilead	Bictegravir	—	COMPLETED	2015-01-23	NCT02275065
ViiV Healthcare	BMS-663068	—	COMPLETED	2015-01-12	NCT02277600
ViiV Healthcare	Ethinyl Estadiol	—	COMPLETED	2014-12	NCT02159131
Sangamo Therapeutics	—	—	COMPLETED	2014-12	NCT01044654
ViiV Healthcare	Dolutegravir Pediatric Granules	—	COMPLETED	2014-09	NCT02185300
ViiV Healthcare	BMS-955176	—	COMPLETED	2014-08-25	NCT02157467
ViiV Healthcare	BMS-663068	—	COMPLETED	2014-07-25	NCT02164045
ViiV Healthcare	BMS-663068	—	COMPLETED	2014-07-24	NCT02138084
ViiV Healthcare	BMS-955176	—	COMPLETED	2014-07-07	NCT02095886
ViiV Healthcare	GSK1265744 Reference formulation	—	COMPLETED	2014-06	NCT02059031
ViiV Healthcare	GSK1265744	—	COMPLETED	2014-06	NCT02027454
Merck	Doravirine	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	COMPLETED	2014-05-12	NCT02089659
ViiV Healthcare	BMS-663068	—	COMPLETED	2014-05-01	NCT02063360
GeoVax, Inc.	JS7 plasmid DNA and MVA62B vaccine	—	COMPLETED	2014-05	NCT01378156
ViiV Healthcare	DTG	—	COMPLETED	2014-05	NCT02082808
ViiV Healthcare	Metformin 500 mg q12h	—	COMPLETED	2014-05	NCT02064374
ViiV Healthcare	GSK1265744 30 mg oral	—	COMPLETED	2014-04	NCT01754116
International Partnership for Microbicides, Inc.	—	—	COMPLETED	2014-03	NCT01755754
ViiV Healthcare	DTG	—	COMPLETED	2014-01	NCT01967771
GSK	GSK2838232	—	COMPLETED	2013-11-21	NCT01802918
ViiV Healthcare	GSK1265744 Oral	—	COMPLETED	2013-11	NCT01593046
International Partnership for Microbicides, Inc.	—	—	COMPLETED	2013-10	NCT01755741
International Partnership for Microbicides, Inc.	dapivirine	—	COMPLETED	2013-10	NCT01731574
Bristol-Myers Squibb	Atazanavir	—	COMPLETED	2013-06	NCT01837719
PX'Therapeutics	EN41-FPA2 HIV vaccine	—	COMPLETED	2013-06	NCT01509144
ViiV Healthcare	Dolutegravir 50 mg	—	COMPLETED	2013-03	NCT01762995
ViiV Healthcare	GSK1265744 injectable suspension	—	COMPLETED	2012-12	NCT01756131

Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in HIV-1 infection

HIV-1 RNA <50 copies/mL (4) HIV-1 RNA ≤ 100,000 copies/mL (1) HIV-1 RNA < 50 copies/mL (1) HIV-1 negative (1) HIV-1 RNA ≤100,000 copies/mL (1)

Novel HIV-1 infection Drugs by Company (New molecular entities)

3 companies have an FDA-approved novel drug for HIV-1 infection.

Merck 2 drugs

Boehringer Ingelheim 1 drug

VIIV HLTHCARE 1 drug

Reformulations (22 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.